Relative Bioavailability Study of a Fixed-dose Combination Dolutegravir/Abacavir/Lamivudine Dispersible Tablet
Status:
Completed
Trial end date:
2016-11-25
Target enrollment:
Participant gender:
Summary
This is an open-label, randomized, crossover study in healthy adult subjects with 5 treatment
groups over 5 dosing periods. This study will evaluate pharmacokinetic parameters and
relative bioavailability of a dispersible, fixed-dose combination (FDC) tablet of TRIUMEQ™
([abacavir, ABC]/[dolutegravir, DTG]/[lamivudine, 3TC]) when dispersed and consumed under
four different dosing conditions in comparison to an oral dose of TIVICAY™ (DTG) + EPZICOM™
(ABC/3TC) non-dispersible tablets administered in the fasted state. Approximately 20 subjects
will be randomized, each to one of 5 treatment groups. The total duration of participation of
a subject in this study will be approximately 10-11 weeks. It will include a screening visit
within 30 days prior to the first dose of study drug, five treatment periods each with a
single dose of study drug per treatment period and a follow up visit within 7 10 days after
the last dose. There will also be a washout of at least 7 days between doses in each
treatment period. TRIUMEQ, EPZICOM, and TIVICAY are trademarks of the GlaxoSmithKline group
of companies.